GE Healthcare Recalls PET Discovery ST 16 Scanners Due to Power Supply Risk
GE Healthcare is recalling 18 PET Discovery ST 16 scanners because the power supply may be expelled. The recall covers units distributed in the US and 30 other countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (expulsion of power supply) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling 18 units of the PET Discovery ST 16 scanner. The recall was initiated because there is a potential for the power supply to be expelled from the device. This hazard applies to the PET Discovery ST 16, as well as the Lightspeed CT scanner and Discovery LS PET CT scanner.
The affected units were distributed worldwide, including nationwide in the United States and in 30 other countries such as Argentina, Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom. Specific serial numbers and codes for the affected units are listed in the official recall documentation.
No specific instructions for consumers or healthcare providers are provided in the source text beyond the identification of the hazard. Users of these devices should refer to the official FDA recall notice for further details on corrective actions.
The recalled product
- Product
- PET Discovery ST 16
- Manufacturer
- GE Healthcare
- Affected units
- 18
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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